[Federal Register Volume 64, Number 94 (Monday, May 17, 1999)]
[Rules and Regulations]
[Pages 26670-26671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12286]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556


Implantation or Injectable Dosage Form New Animal Drugs; 
Ivermectin; Ivermectin and Clorsulon

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of two supplemental new animal 
drug applications (NADA's) filed by Merial Ltd. One supplement provides 
for use of ivermectin injection, and the other provides for the use of 
ivermectin and clorsulon injection, for 28-day persistent control of 
lungworms in cattle. In addition, a tolerance for ivermectin residues 
in cattle muscle is established.

EFFECTIVE DATE: May 17, 1999.
FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578.

SUPPLEMENTARY INFORMATION: Merial Ltd., 2100 Ronson Rd., Iselin, NJ 
08830-3077, is sponsor of NADA 128-409 that provides for use of 
Ivomec Injection (1 percent ivermectin) and NADA 140-833 that 
provides for use of Ivomec Plus Injection (1 percent 
ivermectin and 10 percent clorsulon) in cattle. The NADA's provide for 
use of the drugs for the treatment and control of gastrointestinal 
roundworm, lungworm,

[[Page 26671]]

grub, lice, and mange mite infections, to control infection and to 
protect from reinfection with Dictyocaulus viviparus and Ostertagia 
ostertagi for 21 days after treatment, and Haemonchus placei, 
Trichostrongylus axei, Cooperia punctata, C. oncophora, and 
Oesophagostomum radiatum for 14 days after treatment. Also, NADA 140-
833 provides for treatment and control of liver flukes. Merial Ltd. 
filed supplements to both NADA's that amend their use to provide for 
control of infection and protection from reinfection of Dictyocaulus 
viviparus for 28 days after treatment. The supplements are approved as 
of April 1, 1999, and the regulations are amended in 21 CFR 
522.1192(d)(2)(ii) and 522.1193(d)(2) to reflect the approval. The 
basis of approval is discussed in the freedom of information summary.
    In addition, FDA has revised the tolerances for residues of 
ivermectin to establish an acceptable daily intake and a swine muscle 
tolerance (63 FR 54352, October 9, 1998). At this time, FDA further 
amends the ivermectin residue tolerances in 21 CFR 556.344 to establish 
a cattle muscle tolerance.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of these 
applications may be seen in the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), these supplemental 
approvals for food-producing animals qualify for 3 years of marketing 
exclusivity beginning April 1, 1999, because the supplements contain 
substantial evidence of effectiveness of the drug involved, any studies 
of animal safety or, in the case of food-producing animals, human food 
safety studies (other than bioequivalence or residue studies) required 
for approval of the supplements and conducted or sponsored by the 
applicant. Exclusivity applies only to the additional indication for 
persistent effectiveness.
    FDA has determined under 21 CFR 25.33(a)(1) that these actions are 
of a type that do not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

List of Subjects

21 CFR Part 522

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 522 and 
556 are amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

Sec. 522.1192  [Amended]

    2. Section 522.1192 Ivermectin injection is amended in paragraph 
(d)(2)(ii) in the last sentence by removing ``D. viparus and'' and 
adding in its place ``D. viviparus for 28 days after treatment,''.

    3. Section 522.1193 is amended in paragraph (d)(2) by revising the 
last sentence to read as follows:


Sec. 522.1193  Ivermectin and clorsulon injection.

* * * * *
    (d) * * *
    (2) * * * It is also used to control infections of D. viviparus for 
28 days afer treatment, O. ostertagi for 21 days after treatment, and 
H. placei, T. axei, C. punctata, C. oncophora, and O. radiatum for 14 
days after treatment.
* * * * *

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

    4. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.

    5. Section 556.344 is amended by adding paragraph (b)(2)(ii) to 
read as follows:

Sec. 556.344  Ivermectin.

* * * * *
    (b) * * *
    (2) * * *
    (ii) Cattle. 10 parts per billion.

    Dated: May 3, 1999.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-12286 Filed 5-14-99; 8:45 am]
BILLING CODE 4160-01-F